UMIN-CTR Clinical Trial

Public title

Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing

Acronym

Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing

Scientific Title

Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing

Scientific Title:Acronym

Investigation of safety when using hypoosmotic nonionic iodinated contrast agent in videofluoroscopic examination of swallowing

Region

Japan

Condition

Dysphagia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate whether serious side effects can be avoided by using a hypoosmotic nonionic iodinated contrast agent with less pulmonary toxicity than barium in videofluoroscopic examination of swallowing.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Safety: Within one week after examination in all cases the incidence of side effects (items below)
1.Nausea/itching feeling/rash/vomiting/hot feeling/dizziness/coughing/hypertension or hypotension/sneezing/palpitations/shivering/headache/hot flashes/shock/anaphylactoid symptoms/renal failure/acute respiratory distress syndrome/delirium/confusion/consciousness disturbance convulsive seizure/thrombocytopenia/liver dysfunction/ventricular fibrillation/skin disorders
2.Presence or absenceof to stored in the lung field and the incidence of respiratory failure in aspiration cases

Key secondary outcomes

Evaluation of swallowing function during examination

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Medicine to use:Iopamidol(Oypalomin).
Dosage form:Injection, light shielded, stored at room temperature.
Method of administration:At the time of liquid swallowing evaluation, dilute 15 ml of Iopamidol with 75 ml of water and drink 5 cc, 10 cc, 30 cc. At the time of solid swallowing evaluation, take 1g tincture in 35 ml of Iopamidol diluted with 40 ml of water was used as a food form (jelly, mixer porridge, mixer side dish, rice gruel, carved and thickened side dish, bite size carved and thickened side dish, a rice, a side dish) to be ingested.At the time of thickening water swallow evaluation, take 1 g tincture mixed with 35 ml of Iopamidol diluted with 40 ml of water in 5 cc (small spoon) and 10 cc (large spoon).
Video fluorography of swallowing method: Have an oral intake of Iopamidol in the above ingestion method, evaluate the swallowing function under fluoroscopy on the side, and simultaneously record video and record on recording paper. Oral ingestion is performed in the order of solid, thickening water, water.The solid is applied in the order of jelly, mixer porridge, mixer side dish, rice gruel, carved and thickened side dish, bite size carved and thickened side dish, a rice, a side dish, but in case of aspiration is discontinued.After the examination, reevaluate the swallowing function while watching the neurologist, otolaryngologist, nutritionist, nurse, speech therapist while watched the recording.
Safety assessment of Iopamidol: Observation after 1 week from the examination, when the occurrence rate of side effects and aspiration is observed, the presence or absence of storage in the lung field and the incidence of respiratory failure are counted every year.
Participation schedule: Iopadol administration period during video fluorography of swallowing examination, during observation period 1 week from video fluorography of swallowing examination.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Degradation of swallowing function is suspected by bedside evaluation during hospitalization or outpatient at our hospital, or evaluation of necessity of establishing gastrostomy in future.

Key exclusion criteria

Iodine allergy or serious thyroid disease

Target sample size

600

Name of lead principal investigator

1st name
Middle name
Last name	Shinobu Tochimoto

Organization

St.Marianna University school of medicine

Division name

Department of Rehabilitation

Zip code

Address

Sugao 2-16-1, miyamae-district, kawasaki-city, kanagawa, japan

TEL

044-977-8111

Email

s-tochi@marianna-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinobu Tochimoto

Organization

St.Marianna University school of medicine

Division name

Department of Rehabilitation

Zip code

Address

Sugao 2-16-1, miyamae-district, kawasaki-city, kanagawa, japan

TEL

044-977-8111

Homepage URL

Email

s-tochi@marianna-u.ac.jp

Institute

Department of Rehabilitation, St.Marianna University school of medicine

Institute

Department

Personal name

Organization

non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学病院（神奈川県）

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

During the survey period from April 15, 2015 to March 31, 2017, 452 (300 men, 152 females, average age 69.4 years) were included. Fifty-three patients (11.7%) who had aspiration in video fluorography examination showed no accumulation in the lung field or merger of respiratory failure. The incidence of side effects was one (0.22%) for each of itching sensation, hot feeling, flushing, redness, headache, fever, but no serious complication was observed.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2015

Year

04

Month

08

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

12

Day

Last modified on

2018

Year

03

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029690